中美双报，复星医药子公司复宏汉霖纳武利尤单抗生物类似药HLX18获得中国药监局临床研究批准
2026年3月20日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发的纳武利尤单抗生物类似药HLX18（重组抗PD-1人源化单克隆抗体注射液）的新药临床试验（IND）申请已获得中国国家药品监督管理局（NMPA）批准，拟用于治疗多种已切除实体肿瘤。此前，HLX18的IND申请也已获得美国食品药品监督管理局（FDA）许可。
HLX18是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规开发的纳武利尤单抗生物类似药，经药学和非临床比对研究证明，HLX18与原研纳武利尤单抗相似。目前纳武利尤单抗已在多个国家和地区获批用于黑色素瘤（MEL）、恶性胸膜间皮瘤（MPM）、头颈部鳞状细胞癌（HNSCC）、尿路上皮癌（UC）等一系列适应症。根据IQVIA数据，纳武利尤单抗2024年度全球范围销售额为111.03亿美元。
依托在免疫肿瘤领域的系统性研发能力，公司持续推进覆盖PD-1/L1、CTLA-4等免疫靶点的多元化产品布局，围绕不同肿瘤类型和治疗场景构建互补式适应症组合，覆盖肺癌、消化道肿瘤、黑色素瘤、泌尿系统肿瘤、乳腺癌、淋巴瘤等多瘤种，并系统布局围手术期、一线治疗及联合治疗等关键治疗场景。公司自主研发的抗PD-1单抗H药 汉斯状®（斯鲁利单抗）已在小细胞肺癌、胃癌围手术期治疗等多项核心适应症中展现明确的临床价值，并通过持续推进国际化临床研究与联合治疗探索，构建差异化竞争优势。同时，公司开发的HLX43作为一款潜在同类最优的广谱抗肿瘤PD-L1 ADC，已在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效，并已于近期在美国启动一项针对晚期或转移性鳞状非小细胞肺癌（sqNSCLC）的 II/III期国际多中心临床研究。在HLX18之外，帕博利珠单抗生物类似药HLX17和伊匹木单抗生物类似药HLX13均已完成国际多中心I期临床研究首例受试者给药；达雷妥尤单抗生物类似药HLX15（重组抗CD38全人单克隆抗体）皮下注射剂型（HLX15-SC）的IND申请亦已获得NMPA和FDA许可。
多靶点免疫治疗产品在适应症定位与开发路径上的协同推进，进一步完善了公司在免疫肿瘤领域的整体产品矩阵，并为后续联合治疗及创新疗法探索奠定了坚实基础。未来，复宏汉霖将继续聚焦未满足的临床需求，持续拓宽公司在更多疾病领域的前瞻性布局，为全球患者带去高品质、可负担的创新治疗方案。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EMA上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。
在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。
NMPA Grants IND Approval for Henlius’ Nivolumab Biosimilar HLX18 Following U.S. FDA Clearance
Shanghai, China, March 20, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for HLX18, a proposed nivolumab biosimilar independently developed by the company, has been approved by the China National Medical Products Administration (NMPA) for the treatment of certain resected solid tumors. Previously, the IND application for HLX18 was also cleared by the U.S. Food and Drug Administration (FDA).
HLX18 is a nivolumab biosimilar developed by Henlius in accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Comparative pharmaceutical quality and non-clinical studies have demonstrated that HLX18 is similar to the reference product nivolumab.
Nivolumab has been approved in multiple countries and regions for a range of indications, including melanoma (MEL), malignant pleural mesothelioma (MPM), head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma (UC). According to IQVIA, global sales of nivolumab reached approximately USD11.103 billion in 2024.
Leveraging its integrated R&D capabilities in immuno-oncology, Henlius continues to advance a diversified portfolio covering multiple immune targets, including PD-1/L1 and CTLA-4. The company is developing complementary indication strategies across different tumour types and treatment settings, spanning lung cancer, gastrointestinal cancers, melanoma, urological cancers, breast cancer, and lymphoma, while systematically addressing key clinical scenarios such as perioperative treatment, first-line therapy, and combination regimens.
Henlius’ self-developed anti-PD-1 monoclonal antibody, serplulimab, has demonstrated clear clinical value in multiple key indications, including small cell lung cancer and perioperative treatment of gastric cancer. Through the continued advancement of global clinical studies and combination therapy strategies, serplulimab is building a differentiated competitive profile.
In addition, HLX43, a potentially best-in-class pan-tumour antibody-drug conjugate (ADC) candidate targeting PD-L1, has shown promising preliminary clinical efficacy characterized by encouraging efficacy and manageable safety profile in solid tumors including non-small cell lung cancer (NSCLC). Recently, a global multicenter phase 2/3 clinical study evaluating HLX43 for advanced or metastatic squamous NSCLC (sqNSCLC) has been initiated in the United States.
Beyond HLX18, the pembrolizumab biosimilar HLX17 and the ipilimumab biosimilar HLX13 have both completed first patient dosing in their respective international multicenter phase 1 clinical studies. Meanwhile, the investigational new drug application for HLX15-SC, a subcutaneous formulation of the daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody), has also been cleared by both the NMPA and the FDA.
The coordinated advancement of multi-target immuno-oncology assets, differentiated by indication positioning and development pathways, further strengthens Henlius’ overall immuno-oncology portfolio and lays a solid foundation for future combination strategies and innovative therapeutic exploration.
Looking ahead, Henlius will continue to focus on unmet medical needs, expand its forward-looking pipeline across more disease areas, and strive to provide high-quality and affordable treatment options for patients worldwide.
About Henlius
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products authorized by the European Medicines Agency (EMA), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.
Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
To learn more about Henlius, visit https://www.henlius.com/en/ and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
